The Use of Steri3X for Prevention of Post-operative Wound Infections in Cesarean Sections

Status: Not yet recruiting
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

Postpartum infection is a major cause of maternal morbidity and prolonged hospitalization, and places a large burden on the healthcare system with an additional cost of $3,700 (Olsen et al., 2010). Surgical site infection (SSI) is one of the most common post-operative complications following cesarean section, with an incidence of 3-15% worldwide (Zuarez-Eaaston et al., 2017). Wound dressings that are applied after closure of a surgical incision may help healing by providing physical support, protection from external contaminants, and by absorbing exudate (Dumville et al., 2016). A new FDA-approved microbicidial liquid adhesive, Steri3X, has been shown to reduce the incidence of pin-tract infection by 100% in a randomized-controlled trial following external fixation in patients undergoing reconstructive surgery for deformity correction (Pema, 2020). Steri3X is reported to be effective against S. aureus (both MSSA and MRSA), Candida albicans, E. coli, P. aeruginosa, and Candida auris, which are common organisms involved in dermatological infections. The most common organisms responsible for cesarean section SSI include enteric gram negative bacilli, enterococci, and group B streptococcus (Gur et al., 2015). The advantage of this polymer following C-sections is unknown, and a larger study is needed to provide a more robust analysis. This study aims to determine the effect of Steri3X on the incidence of cesarean section SSI at Regional One Hospital.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 16
Healthy Volunteers: Accepts Healthy Volunteers
View:

• Age 16 years old or older C-section patients only (primary, repeat, or stat) Diabetes, obesity ok to include (but not required) Patients receiving PCN for GBS prophylaxis ok to include (but not required) Application of Steri3X immediately post-op

Time Frame
Start Date: June 2022
Estimated Completion Date: June 2023
Participants
Target number of participants: 1000
Treatments
Active Comparator: Control
Currently, the standard of care for Cesarean section patients includes covering the closed incision with a sterile bandage to reduce the chance of infection, and approximately 48 hours of post-op hospitalization and wound surveillance. The control group will receive post-operative wound dressings consistent with the current standard of care.
Experimental: Experimental
Patients randomized to the Experimental group will receive treatment with Steri3x immediately following closure of the Cesarean section incision. Participants in the experimental group will receive approximately 48 hours of post-op hospitalization and wound surveillance.
Sponsors
Leads: Bethany Erickson

This content was sourced from clinicaltrials.gov

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